PMA approvals

DETOUR System

Endologix, LLC · Stent graft, bypass, superficial femoral artery · Cardiovascular

P220021 S009SupplementOK30
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PMA number
P220021
Supplement number
S009
Applicant
Endologix, LLC
Street 1
3910 Brickway Blvd.
City
Santa Rosa
State
CA
Zip
95403
Generic name
Stent graft, bypass, superficial femoral artery
Trade name
DETOUR System
Product code
QWM
Advisory committee
CV
Advisory committee description
Cardiovascular
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-09-18
Decision date
2026-10-16
Decision code
OK30
Ao statement
approval for changes to visual acceptance criteria for TORUS SGDS Latch and Pulley Subassembly components
Harmonized identifiers (openFDA)
Device name
Stent Graft, Bypass, Superficial Femoral Artery
Medical specialty description
Unknown
Device class
3
Registration number
2030624, 3008011247
FEI number
3000206435, 3008011247
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.